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SensID Idylla™ MSI FFPE Reference Set
Idylla™ MSI FFPE Reference Set is intended as commutable, qualitative control material for microsatellite instability (MSI) markers in FFPE format based on human cell lines. It consists of MSI FFPE MSI-H control with all MSI markers at a frequency of 1x LOD for the Idylla™ MSI Test (refer to Idylla™ MSI Test package insert) and MSI FFPE MSS control with 0% frequency for all MSI markers. This Reference set enables monitoring of the performance, procedures and workflow of laboratory tests using FFPE in combination with the automatic workflow of the Idylla™ platform (Biocartis NV).
Details
Device typeExogenous DNA/RNA internal control IVD, kit: A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen.
FDA categoryQuality Control Material, Genetics, Dna
Device ID04260712780041
Catalog numberSID-000114
Single useYes
MRI safetyLabeling does not contain MRI Safety Information